Exposure to selective serotonin reuptake inhibitor therapy in the last trimester of pregnancy may raise the risk of persistent pulmonary hypertension of the newborn, but that risk is smaller than previous studies have suggested, according to a report published June 2 in JAMA.
Persistent pulmonary hypertension of the newborn (PPHN) is grave, with up to 20% of affected infants dying from the disorder and survivors facing serious long-term sequelae such as chronic lung disease, seizures, and neurodevelopmental problems. The Food and Drug Administration released a public health advisory in 2006 warning that SSRI exposure during late pregnancy may raise the risk of PPHN, based on a single epidemiologic study. Subsequent studies with conflicting findings prompted an update of the advisory in 2011, which concluded that it is not yet possible to determine whether such a link exists.
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To examine the possible association, researchers analyzed information concerning 3,789,330 eligible pregnancies during a 10-year period in a Medicaid database covering 46 states and the District of Columbia. A total of 128,950 of these mothers (3.4%) used an antidepressant in the final trimester: 102,179 used an SSRI and 26,771 used a non-SSRI.
After the data were adjusted to account for the substantial differences between women who used antidepressants and women who did not, the adjusted odds ratio for having a neonate with PPHN was 1.10 for women who used SSRIs and 1.02 for those who used non-SSRIs, compared with nonusers.
This indicates that SSRI exposure “may be” associated with an increased risk of PPHN, but the magnitude of that risk – if present – is smaller than previous studies have reported, Krista F. Huybrechts, Ph.D., of the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and of Harvard Medical School, both in Boston, and her associates reported (JAMA 2015;313:2142-51 [doi:10.1001/jama.2015.5605]).
“Clinicians and patients need to balance the potential small increase in the risk of PPHN, along with other risks that have been attributed to SSRI use during pregnancy, with the benefits attributable to these drugs in improving maternal health and well-being,” they wrote.
This study was supported by the Agency for Healthcare Research and Quality and the National Institutes of Health. The researchers reported having no financial disclosures.